An interventional study of dedicated venous stenting and Dedicated venous stent / iliofemoral dedicated venous stenting in Vascular, DVT - Deep Vein Thrombosis and Post Thrombotic Syndrome, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Outcomes of iliac vein stenting with dedicated venous stents in treatment of chronic post-thrombotic venous ulcers Deep vein thrombosis (DVT) affects 1 to 3 individuals per 1000 annually. Among these patients, 20% to 50% may develop post-thrombotic syndrome (PTS), with the likelihood varying based on the extent and location of the thrombus. Notably, despite receiving anticoagulation therapy, 5% to 10% of patients may progress to severe PTS, potentially leading to the development of venous ulcers (Afsha Aurshina, 2018). Chronic venous obstruction (CVO) refers to the impediment of venous flow, typically resulting from either partial or complete blockage of the venous system. This obstruction leads to diminished venous flow and elevated pressure within the affected veins. CVO serves as a broad descriptor for various conditions, including post-thrombotic syndrome (PTS) and nonthrombotic iliac vein lesions (NIVLs). PTS commonly arises as a complication of deep vein thrombosis (DVT), with estimates indicating that up to 50% of patients diagnosed with iliofemoral DVT will develop PTS within two years following their initial diagnosis. (Mohammad E. Barbati, 2024)
The study aims to know the outcomes of iliac vein stenting with dedicated venous stenting in the treatment of post-thrombotic syndrome venous ulcer.
Type of Study: Prospective single arm cohort study
Study Tools
Study Procedures and Interventions:
All participants will receive standardized venous ulcer care, including wound assessment, appropriate dressing according to the amount of exudate, and elastic compression using class II elastic stockings. Wound care will be provided twice weekly in the vascular surgery clinic by the study investigators. Debridement and wound culture with sensitivity testing will be performed when clinically indicated.
Participants assigned to the interventional treatment will undergo endovascular iliac venous recanalization and stenting. The ipsilateral great saphenous vein, popliteal vein, or femoral vein will be used as the preferred venous access according to the anatomical characteristics of each case. Procedures will be performed under ultrasound guidance.
After venous access, an antegrade venogram will be obtained to assess the venous anatomy and determine the location and extent of iliac venous obstruction. A guidewire will be advanced across the obstructed segment, followed by balloon venoplasty using an appropriately sized balloon. A dedicated self-expanding venous stent will then be deployed across the obstructed segment. Stent diameter will be selected according to the venous anatomy and vessel dimensions, with adequate post-dilatation when required. Completion venography will be performed to assess the final venous flow and stent position.
Following the procedure, venous access sites will be compressed with a sterile dressing. Antithrombotic treatment will be administered according to the study protocol. Low-molecular-weight heparin will be administered at a dose of 5000 IU every 12 hours after stent implantation, followed by therapeutic anticoagulation with warfarin targeting an international normalized ratio of 2-3 or rivaroxaban 20 mg once daily for at least 1 year after hospital discharge.
Postoperative Follow-up:
Clinical follow-up will be performed at 7 days, 1 month, 3 months, 6 months, and 12 months after treatment. Follow-up assessments will include venous ulcer healing, ulcer diameter and depth, time to complete healing, and changes in venous clinical severity and quality-of-life scores. Venous duplex ultrasound will be performed during follow-up to assess stent patency. Computed tomography venography will be performed in cases of suspected stent occlusion, recurrent symptoms, or recurrent venous ulceration.
785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.
This study's planned enrollment of 20 is below the median of 152 across 477 interventional studies indexed under Venous Thrombosis.
Browse Venous Thrombosis studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Life expectancy
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Participants with chronic non-healing venous ulcers associated with iliofemoral post-thrombotic syndrome will undergo iliofemoral venous balloon venoplasty and dedicated venous stenting in addition to standard venous ulcer care and compression therapy.
Procedure: dedicated venous stenting · Device: Dedicated venous stent / iliofemoral dedicated venous stenting
iliofemoral dedicated venous stenting
Also known as: venoplasty
Participants with chronic non-healing venous ulcers associated with iliofemoral post-thrombotic syndrome will undergo iliofemoral venous balloon venoplasty and dedicated venous stenting in addition to standard venous ulcer care and compression therapy.
complete healing of venous ulcer
Proportion of participants with complete healing of the venous ulcer at 12 months after iliofemoral venous stenting.
Time frame: 12 months
Time to complete venous ulcer healing
Time from venous stenting to complete healing of the venous ulcer, measured in days.
Time frame: 12 months
Change in rVCSS
Change in revised Venous Clinical Severity Score (rVCSS) from baseline to 12 months after treatment.
Time frame: 12 months
Venous ulcer recurrence
Proportion of participants with recurrence of a previously healed venous ulcer during the 12-month follow-up period.
Time frame: 12 months
Plan to share: Yes — Share for MD
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Started Mar 2025 (actual). Primary completion is estimated for Dec 2026, 21 months after the start.
Of 99 non-industry interventional studies with no phase under Venous Thrombosis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's planned 21 months is below that.
Counting every sponsor, half of 117 studies reached it within 34 months; a quarter within 13 and three quarters within 56.
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